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CTRI Number  CTRI/2025/07/090344 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 07/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Two Patient Positions During Surgery for Thighbone Fractures: Which Position Helps Bone Heal Straighter 
Scientific Title of Study   ROMANOFF - Rotational Malalignment in Nailing of Femur Fractures - A Comparative Randomized Study between Supine and Lateral Position 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gokulprasath S 
Designation  MS ortho, Assistant professor  
Affiliation  Christian medical College vellore  
Address  7th floor, A block, Department of Trauma orthopaedics, Christian medical College, vellore, Ranipet campus,Ratnagiri Kilminnal

Vellore
TAMIL NADU
632517
India 
Phone  9994390198  
Fax    
Email  gokulprasath92@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gokulprasath S 
Designation  MS ortho, Assistant professor  
Affiliation  Christian medical College vellore  
Address  7th floor, A block, Department of Trauma orthopaedics, Christian medical College, vellore Ranipet campus,Ratnagiri Kilminnal

Vellore
TAMIL NADU
632517
India 
Phone  9994390198  
Fax    
Email  gokulprasath92@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gokulprasath S 
Designation  MS ortho, Assistant professor  
Affiliation  Christian medical College vellore  
Address  7th floor, A block, Department of Trauma orthopaedics, Christian medical College, vellore,Ranipet campus,Ratnagiri Kilminnal

Vellore
TAMIL NADU
632517
India 
Phone  9994390198  
Fax    
Email  gokulprasath92@gmail.com  
 
Source of Monetary or Material Support  
Christian Medical College, Vellore, Tamilnadu, India - 632004 
 
Primary Sponsor  
Name  Christian Medical College Vellore  
Address  Christian Medical College Vellore, Tamilnadu, India - 632004 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gokulprasath   Christian Medical College   Department of Trauma orthopaedics, Ranipet campus, Ratnagiri Kilminnal - 632517
Vellore
TAMIL NADU 
9994390198

gokulprasath92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board Christian Medical College Vellore   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S723||Fracture of shaft of femur, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lateral position nailing  Nailing of femur Fractures which will be done in lateral position on radiolucent table 
Comparator Agent  Supine position nailing   Nailing of femur Fractures which will be done in supine position on fracture table 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult aged 18 years of age or older presenting to casualty or OPD
Diaphyseal femur fractures A0 32 appropriate for antegrade nail fixation
Ability to obtain perioperative imaging (CT scans)
Provision of informed consent
Enrolled within 3 weeks of femoral shaft fixation
Open fractures Gustilo Anderson type 1, 2, 3A
Bilateral femur fractures 
 
ExclusionCriteria 
Details  Ipsilateral neck of femur fractures
Distal femur shaft fractures amenable to retrograde nail fixation
Ipsilateral tibia fractures
Ipsilateral acetabular fractures
Periprosthetic fractures
Pathological fractures
Open fractures Gustilo Anderson type 3B, 3C
Inability to be positioned in lateral decubitus because of a concomitant injury
Contraindications to CT imaging including impaired kidney/liver function, or lack of timely availability
Pregnancy (due to decubitus positioning) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare post-operative rotational alignment of operative limb with CT scan axial images after surgery using 2 positions
 
1st postoperative day
 
 
Secondary Outcome  
Outcome  TimePoints 
Pain score at 6 weeks, 3 months & 6 months using VAS score
Functional score by a LEFS (Lower Extremity Functional Scale) score at 6 weeks, 3 months & 6 months.
Knee ROM at 6 weeks, 3 months & 6 months.
Time to union
Operative time between two groups
Number of open reductions
Intraoperative complications such as perineal skin & soft tissue compromise
 
6 weeks, 3 months & 6 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Femur shaft fractures are among the most common orthopaedic injuries, and intramedullary nailing is the standard treatment of choice for these fractures. It aims to achieve alignment, length, and stabilization with minimal soft tissue dissection. The advantages of the nail include early weight-bearing and joint mobilization. There are many ways to perform fracture fixation, including variations in the entry point, implant choice, patient position, and operating table. Antegrade intramedullary nailing is the preferred choice for most femur shaft fractures, except for distal third shaft fractures, which are sometimes amenable to retrograde nailing.
Common positions used for antegrade nailing of femur fracture fixation are:
Supine position on a fracture table
Lateral decubitus position on a radiolucent table

The use of a fracture table with patient in supine position has become the preferred
treatment for most of these fractures. Literature shows that there can be rotational malalignment following antegrade intramedullary nailing of femur fractures. Malrotation mainly occurs because the traction table can easily overpower the patient’s resting muscle tension, as well as due to the surgeons manipulation when reducing the fracture during positioning. It has been hypothesized that the lateral position provides easier access to the entry point, facilitates fracture reduction, and allows for rapid implant positioning. Although rotational malalignment can occur in both positions, according to the literature, the lateral position provides better fracture reduction and control of fracture fragments. There are many ways to determine femoral rotation which includes clinical assessment, radiological measurement, Ultrasound and CT. Unlike when using radiography or ultrasound, the
position of the patient does not influence the accuracy of CT measurement of femoral rotation. Hence in this study we plan to use CT as a definitive tool to evaluate the impact of patient positioning on rotational alignment. 

 
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